Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
Tuesday 2nd February 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.

[Baroness Thornton (Lab)]

My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.

We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.

Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.

Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.

The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.

Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.

Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.

Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.

These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.

[Baroness Thornton (Lab) [V]]

My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.

Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.

Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that

“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.

This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.

Amendment 21 would ensure that patient information

“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”

We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.

Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.

Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.

Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.

At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.

The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.

I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.

As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?

[Baroness Thornton (Lab)]

My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

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[Baroness Jolly (LD) [V]]

My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.

Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.

The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.

One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.

We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.

[Baroness Thornton (Lab)]

The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.

I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.

As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.

--- Later in debate ---

[Baroness Jolly (LD) [V]]

My Lords, this amendment, led by my noble friend Lord Clement-Jones, would narrow the use of data in relation to falsified medicines to that which ensures patient safety. The use of patient data is a really delicate issue. As currently drafted, Clause 3 allows for regulations to be made about

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”

The Minister has said that we want to explore creative uses of information. I am not quite sure what the general public would think of that statement. I am not quite sure what I think of that statement. As my noble friend Lord Clement-Jones has said, this is an incredibly wide remit granted to the Government. Restricting it to information that ensures patient safety, as in the amendment, will help protect patients’ information. In his summing up I would like the Minister to outline how this amendment will work in practice, and we will consider whether this might be brought back at Third Reading.

[Baroness Thornton (Lab)]

I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.

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[Baroness Jolly (LD) [V]]

My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.

The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.

Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.

[Baroness Thornton (Lab)]

The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”

“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.

So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.

Covid-19 Update

Debate between Baroness Jolly and Baroness Thornton

Tuesday 15th December 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for the debate today. A total of 34 million people will be living under tier 3 Covid rules from midnight tonight after London, parts of Essex and Hertfordshire were placed under the most severe level of restrictions. My first question for the Minister is: what have been the criteria for deciding these tiers, and will the Government commit to publishing the rationale for their decisions?

It was noticeable during the Statement yesterday that the Secretary of State spoke with firmness and confidence when he announced the new restrictions and why he was making them, and spoke about the worrying new strain of the virus. It was only when he was pressed on the effect of, and scientific story behind, the Christmas relaxation that he became less sure. One has to ask why that might be the case.

Talk of acting decisively and boldly seemed to go out of the window. In its place came fudge and obfuscation, dither and blather. Professor Chris Whitty, when commenting on the Christmas rules, said:

“This is, in a sense, a limited relaxation which will have some impact on the upward pressure on the coronavirus.”


Well, yes. The Government’s answer seems to be to fall back on ‌the idea that this is all about “personal responsibility”—about the public taking a minimalist interpretation of the rules, not a maximalist one. The Health Secretary eventually gave a vague bit of concrete advice on Christmas, coming close to saying that we should self-isolate for a few days before meeting grandparents.

“The best thing you can do if you want to see elderly relatives at Christmas is to be extremely careful now about who you see”


was how he put it.

I therefore have to ask the Minister whether the Christmas relaxation is being reconsidered. What is the Secretary of State’s plan to keep people safe through Christmas and avoid huge pressures on the NHS in January? What is his plan to support an exhausted, underfunded and understaffed NHS through January to deliver the care that patients will need? Is he confident that our NHS will not be so overwhelmed in January that it impacts on the vaccination programme? Will the Government publish an impact assessment on their decision to allow a temporary relaxation that will allow three households to mix over the festive period?

This is a virus that, without adequate restrictions in place, spreads with ferocity. Case rates are increasing again, hospital admissions are climbing and the R is edging up. Last week, the England-wide rate was 159 per 100,000; now it is 188 per 100,000. That is a 20% increase. Across London, cases have increased by 30% and across the east of England by 36%. None of us is therefore surprised at the action that the Secretary of State took yesterday. Indeed, he was warned that tier 2 would not be enough to contain the spread of the virus in many places. It looks as though in some areas, such as Kent, tier 3 is not enough to contain the spread there.

Elsewhere in the country, tier 3 appears to be forcing the virus to flatline. Indeed, in the north-west it is trending down. However, overall, cases in the increasing areas are rising faster than those in the decreasing areas are falling. As things stand, we are heading into the Christmas easing with diminishing headroom. As my honourable friend Jon Ashworth said yesterday:

“The buffer zone that the tiers were supposed to provide is getting much thinner.”—[Official Report, Commons, 14/12/20; col. 25.]


London, like other parts of the country, will now suffer dreadfully from these further restrictions, which we support, but we think there are some serious problems. Businesses and livelihoods will suffer and there will be a cost to mental health and our NHS. The Minister has often praised Liverpool, but is not the biggest lesson to draw from Liverpool that people still struggle to isolate if they do not have the financial means to do so? The eligibility criteria for the £500 payment are still too tightly drawn: people need decent sick pay, people in some circumstances need alternative accommodation and people need help with their shopping and medicines. Surely, some of the £22 billion spent on test and trace could be reallocated to offer people adequate isolation support—as has happened elsewhere in Europe and the world?

Why is there still not a plan to make lockdown easy for people to do? Will the Government address the wide gaps that exist in economic support for the self-employed, for example? The IFS has noted that many would

“fall through the gaps completely”

and estimated that nearly two in five people with some self-employed income were excluded from the Government’s support schemes—this is not adequate.

I turn to the vaccine. Can the Minister update us on how many people have received the vaccine? Can he set out exactly when unpaid carers will be given the vaccine, given that they spend their time caring for extremely vulnerable people and could pass on the virus? I echo what my honourable friend Jon Ashworth said in the other place yesterday, when he asked whether priority could be given to those who are terminally ill to get the vaccine as soon as possible.

Can the Minister also explain what guidance is being put in place for autistic people, for example, in in-patient settings to go home for Christmas? Autism charities have warned that autistic people in residential care will have to isolate for 14 days when they come back from visiting their families—that is not fair on those who need routine and support. The Government must make their guidance autism-friendly.

The PHE report last month found that people with learning disabilities had a death rate 4.1 times higher than the general population, and this could be 6.3 times higher—what steps are being taken to protect them as infections rise? In November, the Minister in the other place said she was asking SAGE to review this report and make further recommendations; what is the outcome of that?

[Baroness Jolly (LD) [V]]

I support the points made by the noble Baroness, Lady Thornton, on lockdown; she and I have repeated them regularly in these debates, and yet there is no change. My points will be around vaccines, acute hospitals and their staffing, and Christmas. I thank the Minister for repeating the Statement and join him in welcoming the news about vaccines. Anyone in need of a real feelgood story should watch last night’s “Panorama” programme about the development of the Oxford team’s AstraZeneca vaccine.

How confident is the Minister of 100% vaccine coverage, for those that are entitled, by Easter 2021? This is a lot of people, and we are not certain of all vaccines being available by that time. Could he explain to the House what determines who receives the AstraZeneca vaccine and who the Pfizer—or indeed any other vaccine that may come along? Is he confident that the new vaccines will be effective against the new variant that is emerging?

Can the Minister give us a statement about acute hospitals in tier 3 areas? At the moment, it looks as though the rise in cases in the London area and the south-east is almost matched by the rise in hospital admissions—they are just a percentage point apart. Are the Government confident in London’s hospital capacity? We know that, in some areas, there are Nightingale hospitals; is the NHS intending to bring them into use if necessary? Are there the clinical and other staff to run them?

For many of us, an in-person Christmas may not be possible. We need to look at the impacts that Thanksgiving had on the US Covid-19 figures and assess our risk. Many of my contemporaries have decided not to travel to celebrate with friends and family, and our children have told us that this is what we are going to do as well, so it looks as if many will be resorting to whatever is their favourite conferencing software to catch up with family.

Finally, will the Minister outline the Government’s communication strategy for Christmas? Clear messaging is imperative but many of the public who have been interviewed are unclear. Will ads be used in newspapers, broadcasts and online social media? Christmas is 10 days away, and people would appreciate a clear steer from the Government. This needs urgent and professional communications attention.

Covid-19 Update

Debate between Baroness Jolly and Baroness Thornton

Monday 30th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for taking this Statement, and I look forward to discussing the regulations that will flow from it tomorrow, if they successfully pass through the Commons. Although we can see that cases are going down—and that, of course, is a matter for celebration and relief—we are still seriously in the pandemic. We still seriously stuck in what seems like an endless cycle of lockdowns, which have not been working.

The Government have again wasted the opportunity, over the past few months, to get a handle on testing, tracing, isolating and supporting. Once again the hospitality industry in many parts of the country will be absolutely battered. Once again jobs will be in further jeopardy. Once again our theatres are closed. Once again older people, disabled people and people with learning difficulties remain stranded in care homes without visits from their families. Exactly what will be the difference this time that will make people’s sacrifices yield a reduction in the infection rates? When shall we see testing in care homes, for example?

Reflecting on the debate in the Commons following the Prime Minister’s and the Secretary of State’s announcements last week, we see that all MPs of all parties were desperate for two things. They were desperate to understand the basis on which these decisions were being taken, and they were desperate to understand how their constituents might be able to move from, for example, tier 3 to tier 2, or tier 2 to tier 1.

As my honourable friend Rachel Hopkins MP says:

“The good people of Luton will want to get out of tier 2 as soon as possible, but the current resources provided to Luton Borough Council for the lateral flow rapid testing pilot are insufficient to enable it to provide the level of mass testing that is being described nationally. The contained funding—£8 per person—just will not cover tests for 10% of Luton’s population, as the funding also needs to be used for the wider covid response, including wellbeing support for vulnerable residents.”


She asked the Secretary of State, and I now ask the Minister here, to

“confirm that there are national plans to provide additional support and resources to expand testing if the intention to test close contacts daily is pursued”.—[Official Report, Commons, 26/11/20; col. 1012]

The news about the vaccine is the light at the end of the tunnel, but noble Lords must be well aware that we are still well into the tunnel, and probably will be for months to come. The only sure way to contain the virus is for people to obey personal rules and, most crucially, for us to have an effective and locally controlled test, trace, isolate and support system. We on these Benches have known this and have been asking, if not begging, for the last part of this deal for many months. Despite the Minister’s constant issuing of large numbers one way or the other, it is still not working as it should be. It is not surprising that confidence in the Government’s ability to deal with the pandemic is at a low ebb, much lower than in March and April.

Yesterday I heard the Conservative Rother Valley MP Mr Stafford say on television that he thought we were in trouble with this virus because people had broken the rules—in other words, let us blame the public. He was taken to task firmly by my honourable friend Naz Shah MP, but I have to ask the Minister whether he agrees with his colleague Mr Stafford.

When areas such as Bury and Trafford went into lockdowns in the summer, the Secretary of State promised that MPs would be involved in the decision. Has that commitment now been abandoned? Then Ministers agreed to involve regional leaders but, it has to be said, took exception to being challenged by Andy Burnham. What role do regional leaders now have in these decisions, or is the position really that the Prime Minister imposes from Downing Street restrictions on communities across the Midlands and north that will have huge impacts on the livelihoods of families and small businesses? What are the plans to alleviate the hardship that these rules will create? Leicester, Bury, Leigh and Heywood have been under a form of lockdown for months, with families forced to part and grandparents not seeing their grandchildren. Those families will want to know today what the exit strategy is and what voice they have in that strategy.

The Secretary of State in this Statement has outlined five criteria by which local lockdowns will be judged. Will that be published, with clear, transparent rules for areas entering and leaving tiers and a scorecard for every area, assessing its Covid progress against its criteria so that everyone can judge this in a transparent fashion?

What have the SAGE advisers said to the Minister about the risks which go with the proposed lifting of restrictions for Christmas? The Canadians have a very clear message about this. They say, “Stay home and stay safe”, and the reason they say that is because the worst surge in Covid-19 they have ever experienced followed six weeks after their Canadian Thanksgiving. They have given warning to their southern neighbours—the United States—that they will see an even bigger and more devastating spike following their annual gathering for turkey and gratitude at Thanksgiving. This is a warning that we need to heed. Does the Minister agree?

[Baroness Jolly (LD) [V]]

I thank the Minister who is going to respond to this Statement.

The first case of this coronavirus was just over a year ago, on 17 November 2019. Since then, over 1.3 million people have died worldwide and over 50 million people have been infected. The first case here in the UK was on 29 January this year. We watched Italy deal with the cases in late winter, and I am sure that plans were being fetched out of the archives on how we might deal with a pandemic. I know that in 2015 there was a pandemic plan published for an influenza outbreak. Will the Minister tell the House what lessons were learned from that exercise?

I remember walking back to my flat in London on 17 March and my son, who was living with me then, said, “You either go home today, or you stay until this clears”. I went home, and on 23 March lockdown started. Along with many other noble Lords, I stayed away for some considerable time, and Zoom, Teams and virtual working became the new normal.

Hong Kong, which is always waiting for a SARS outbreak, keeps a stock of PPE for all care homes in the event of a pandemic. Is it too early to ask the Minister whether that is something he would now consider for England? I think it was a recommendation of that pandemic preparedness document in 2015.

One area where I would also be grateful for clarification is that of test, track and isolate. At what stage was it decided not to involve the local experts and local authorities? This caused much regional frustration, as this was the biggest public health crisis for many years, and local public health leaders were being sidelined. They know their regions well, and in areas where they did work, it worked well. Let me be clear that in a Lib Dem world, local authorities would test then track those with a positive result and support them practically and emotionally in their isolation.

As the noble Baroness, Lady Thornton, has articulated, many of the public have said that they did not fully understand restrictions. When putting messages together, who did the Government picture they were talking to? From whom did they get their advice? Who did they test their messaging on? This is a case where conversations with the Plain English Campaign, or perhaps the Canadians, would have been helpful.

The last time tiered restrictions were in place, less than half of people in the UCL Covid-19 Social Study said that they fully understood the rules. With changes to the tier system and a five-day relaxation, will the Secretary of State make changes to the Government’s communications strategy to aid compliance?

Some of the Covid economic measures have helped people in the short term, such as the furlough scheme, which our colleagues in the other place fought so hard to get. However, the Government excluded more than 1 million people from Covid support and froze pay for local authority staff, who have also played a vital role in combating this pernicious disease. It is an assault on local authority workers and services.

Nurses too have been hoping for a pay rise. The Chancellor stated:

“Our health emergency is not yet over and our economic emergency has only just begun”.


He explained that the

“immediate priority is to protect people’s lives and livelihoods”,

and that the spending review is set to deliver stronger public services. He continued:

“taking account of the pay review bodies’ advice, we will provide a pay rise to over a million nurses, doctors and others working in the NHS.”

He promised

“the 2.1 million public sector workers who earn below the median wage of £24,000”

that they

“will be guaranteed a pay rise of at least £250.”—[Official Report, Commons, 25/11/20; cols. 827-28.]

That should include porters, auxiliaries, and other key, low-paid hospital workers.

Countless families are facing serious financial hardship. More than 1 million people have lost their jobs, and the devastating impact of this pandemic will continue to be felt acutely throughout the next year. We are also facing big challenges in deep-seated inequality. We must ensure that no one is left behind. The Government win plaudits for the furlough scheme, but they have failed to provide a serious economic strategy for dealing with unemployment, climate change and inequality. I fear the Government’s Brexit plans will make job losses and business closures much worse. No deal or a bad deal would be a huge blow for businesses and jobs just when we need to be recovering from this crisis.

Although the winter plan broadly outlines the five criteria used for determining the tier system, would the Minister be more transparent about what the exact entry and exit points of the tiers will be? I understand it is not always possible to give exact criteria, but even a rough idea would help the public know what they are aiming for when the Government are asking them to make so many sacrifices.

This has been relentless since the middle of May. At a briefing meeting today, we heard that the acute care sector was at full pelt, and this is before winter sets in. The Minister is rightly proud of the Nightingale units. Do we have staffing for them? Should we need them? Many clinical staff are totally exhausted. Many question whether they want to carry on in the profession. Are the Government making sure that a safety-critical profession can reach safe staffing levels by filling tens of thousands of unfilled nursing jobs?

Children are the most vulnerable to the social impacts of local restrictions and have had formative years of their lives severely affected. With the rule of six being reinstated after national lockdown, will the Minister commit to an exemption from the rule of six for children under 12? It really does make sense.

What is the Minister’s current estimation of the likely length of the restrictions? Being open and transparent on likely timings and not creating false hope are critical to maintaining public support for any public health measures. After all, the PM said earlier this year that we would be back to normal by Christmas, and how wrong he turned out to be.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.

A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.

Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.

Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.

Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.

Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.

[Baroness Thornton (Lab)]

My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.

The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.

Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.

Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.

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[Baroness Jolly (LD) [V]]

I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold

“relating to a medical device where there is a clear threat to public safety.”

Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.

I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?

More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?

[Baroness Thornton (Lab)]

I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to

“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,

the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?

The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?

Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.

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[Baroness Jolly (LD) [V]]

My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.

At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.

The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.

I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.

[Baroness Thornton (Lab)]

The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.

After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to technologies. Amendment 83, from the noble Lord, Lord Freyberg, to which I have added my name, seeks to improve how the Bill addresses new technologies which have significant potential for harm, and it aligns with and improves on the EU and US equivalents. The critical issue is: what is a medical device? Amendment 113, also from the noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones, updates the definition of a medical device to bring it in line with the EU and US regulation, acknowledging the progress of technology beyond the Medical Devices Regulations 2002, which, in the world of programming, is very nearly the dark ages. I wonder if noble Lords remember ALGOL, FORTRAN and BASIC.

I support Amendment 83, to which I have added my name, and received a very helpful letter about Amendments 112 and 113 from the noble Lord, Lord Freyberg. I listened very carefully to both him and, of course, my noble friend. I am happy to support their arguments and their amendments.

[Baroness Thornton (Lab)]

My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.

It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.

The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.

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[Baroness Jolly (LD) [V]]

My Lords, the amendment from the noble Baroness, Lady Finlay of Llandaff, would require the Secretary of State to introduce a scheme to promote the availability of innovative medical devices for human use within the NHS. The scheme would be known as the NHS innovative medical devices fund.

The Secretary of State is charged with providing the funding and I welcome that approach. She has explained that custom-made devices are both difficult and expensive to fund, especially for the subsequent development of innovative devices with repeated trials. It can also be frustrating. A medical devices fund could take an innovation from concept through its development to production and then be rolled out widely, with any gains being returned to the fund or to the NHS organisation hosting the work. Clearly, flesh needs to be put on to those bones, but as I explained in an earlier Committee session, there is a fund that is particular to orthopaedics which is managed by a charity. In effect, every year it calls for bids, often from start-ups. It supports a certain number of the bids and any profits come back to the charity, which can also choose to be a partner in the venture. Some of the bids come from academia and others from within the NHS, but it works.

[Baroness Thornton (Lab)]

This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.

In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.

[Baroness Thornton (Lab)]

My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.

Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.

Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.

The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.

Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.

[Baroness Thornton (Lab)]

This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.

I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.

All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.

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[Baroness Jolly (LD) [V]]

My Lords, the noble Lord, Lord Patel, set the tone for this debate. I share the concerns of the noble Lord, Lord Hunt of Kings Heath; his concerns should concern us all. We are entering new territory. We have worked across an EU framework for a long time and are now going to be on our own. We need to work out policies and procedures to deal with this new landscape, which of course is what we are doing today. However, we will still have to work with Europe, if not within it.

I understand that we are to leave on 31 December, but we really must not bury our heads in the ground. Regulation will be key; mutual recognition is important. I think the Minister has referred to mutual recognition in the past. I wonder if he or the noble Baroness, Lady Penn—I am not sure who will be summing up—could clarify that issue. We need easy and ready access to new medicines, early-phase trials and the willingness of the NHS to take them up. There is also the role of NICE. We have not looked at mutual recognition of standards, but we need to share information with international partners. My noble friend Lord Clement-Jones asked a lot of pertinent questions. If the Minister does not have these issues in her brief, perhaps we might have either a letter or a meeting, because these are really meaty issues that we are discussing.

Amendment 27 would make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay so that the UK can get early access to new medicines. Amendment 45 would require the Secretary of State to publish their proposed regime for a list of fees in respect of human medicines. What is the timescale on that? It would be interesting to see this fees regime alongside the old regime that we will be leaving.

Government Amendments 48 and 66 relate to the disclosure of information in accordance with international agreements. My noble friend Lord Clement-Jones had something to say about that. Interestingly, although I am not absolutely clear, Labour’s Amendment 118 aims to protect medicines and medical devices regulations from any form of control from outside the UK in the event of a trade deal. This goes back to legislation that we dealt with, which I think we ended up renaming the international health Bill. We need to be clear, coming up to the end of the year, about what a trade deal might actually look like and what things would look like without a trade deal. Those are my reflections on the amendments.

[Baroness Thornton (Lab)]

This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.

I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.

I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:

“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”


The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.

One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.

Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.

The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Baroness Thornton (Lab)]

I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.

Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.

However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.

We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.

If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.

[Baroness Jolly (LD) [V]]

With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.

Covid-19

Debate between Baroness Jolly and Baroness Thornton

Tuesday 20th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, first, I declare my interests in the register.

I thank the Minister for taking both these Statements, because we are in fact updating ourselves on Thursday’s and Monday’s Statements. Without doubt, the virus continues to grow. The R rate is now between 1.3 and 1.5, unless it has increased in the past 24 hours. We on these Benches welcome the advances in saliva and LAMP testing, of course. Indeed, I join everyone in being in awe of the work being carried out in our universities.

I will briefly describe the real-life experience of Test and Trace that happened to a neighbour of mine and her family in the past few weeks. After the first member of the family tested positive, they were given one ID and told to isolate for 14 days as a contact of that family member. The remaining members of the family tested positive four days later. They were given a second ID as a positive contact and told to isolate for 10 days. They all then gave each other’s names to Test and Trace as contacts—of course they did; they live in the same house—and were given a third ID. They were then rung up and told to isolate for another 14 days. When they put their test results into the app, they were given a fourth length of time to isolate, which did not match up with what they had been told on the phone. The various Test and Trace staff did not seem able to collate the information that they were being given or to join it up—although some of them tried, it must be said.

It is not surprising, then, that a significant number of people are not complying with self-isolation advice. They may not even understand it. This family, all of whom were being contacted several times a day by phone and text, felt that they were caught in a Kafkaesque world where they were given different advice daily. One said that when the Test and Trace adviser rang her to say that she could go out on Saturday morning, she was afraid to leave the house until the day after because that was what the app told her.

Everyone in that household wanted to get this right; indeed, they tried very hard to do so. What is being done better to make sure that people are being given clearer advice and to ensure that the Test and Trace system is keeping up with people’s changing circumstances? What efforts are being made to match up what the app tells people and what they are being told to do over the phone?

While all these resources are being expended on one family, we know that others are finding it difficult to get tests at all. The Government promised millions of tests a day. Now, 300,000 are happening per day, with the Secretary of State telling us that there will be 500,000 tests a day by the end of the month. Despite the hard work of Test and Trace workers on the ground, we know that the system is in chaos. People are not getting test results within 24 hours, and many people are still having to drive miles to a drive-in centre to get a test. If they send away for a test, it can take up to a week between ordering the test and getting a result back, especially if the test is delivered at the weekend. People are also being urged to take a test only if they have symptoms, yet we already know that up to 80% of people who have the virus have no symptoms. Once people test positive, they are being given contradictory advice about isolation times.

This virus spreads with speed, so testing must be quick, yet results are not being turned around within 24 hours. Again, when will that happen? Contacts must be traced quickly and those who are traced must be given support to isolate. Yet, to be frank, we have a badly designed system that is failing to trace sufficient contacts, has cost £12 billion so far and is paying consultants £7,000 a day. The Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, the right honourable Michael Gove, justified these failings on “The Andrew Marr Show” by saying that, when the virus is escalating,

“any test and trace system of whatever kind has less utility.”

I wonder what on earth that means. Perhaps the Minister can explain it to me.

Do the Government have confidence in the leadership of Test and Trace, now that we know that so much money is being spent on it? The Minister’s honourable friend Sir Bernard Jenkin MP said yesterday:

“May I also emphasise that one of the reasons why public confidence in the Government’s strategy is somewhat in decline is that we have yet to see the transformation of the leadership of test and trace, which I have discussed with the Secretary of State many times?”.—[Official Report, 19/10/20; col. 784.]


The Secretary of State did not seem to have any answer to his honourable friend’s question. Perhaps the noble Lord could have another go.

What is the estimate of the number of Covid-19 tests that will be delivered per day by the end of the year? As winter is coming, healthcare workers will also need constant testing. Can the Minister guarantee that all healthcare workers and care workers will be able to have quick Covid tests this winter? The Secretary of State has said that quick tests are now being bought. When will they be ready and rolled out?

I understand that a Statement is being made right now in the Commons about the situation in Manchester and the lack of support for low-paid workers and the self-employed if they move to tier 3. If a person works full time for a minimum wage, their take-home pay will be based on £8.20 an hour. If that is reduced to two-thirds, it is £5.47 an hour. Does the noble Lord think that that is a reasonable amount of money for a family with children? Why do he and his colleagues feel that it is acceptable to ask their fellow citizens to live on such a small amount? Why are we not continuing the furlough scheme?

If the mayor, Andy Burnham, and the leaders of all the boroughs in the Manchester area seem to be angry, it is because they know and understand the hardship which the noble Lord’s Government are visiting upon their communities—people who are already living on low wages—and the effect that this will have on them and their children.

[Baroness Jolly (LD) [V]]

Next week is half term. If one looks at the graphs, the south-west looks to be a good destination for the week. I live in Cornwall and tourism is vital to our economy, which was already blighted in the earlier holiday seasons this year. We need visitors and we are ready. What guidance would the Minister give those visitors about the need for social distancing and the wearing of masks? In the summer, there was a reluctance in some cases to comply; many just said that they were on holiday.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Thornton

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Jolly (LD) [V]]

I speak in support of these amendments in the names of my noble friend Lord Sharkey and other eminent noble Lords. I confess that I had not heard of the super-affirmative procedure until my noble friend sat me down and talked me through it, and it struck me as being eminently sensible and doable, and this is exactly the right sort of Bill—or the regulations contained herein are exactly the right sort—for the super-affirmative procedure. I ask all noble Lords to support this amendment and those who support it.

[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

Covid-19

Debate between Baroness Jolly and Baroness Thornton

Thursday 3rd September 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for the Statement and the Covid update that the House will discuss today. We are, of course, all on the same side in fighting this virus. I hope the Minister will understand that when we raise issues it is to urge the Government to improve their response to fighting the virus which, as he said earlier today, remains lethal and leaves many with serious, debilitating sickness. Everything must be done to drive down and eliminate infections and suppress the virus completely.

Given the news today about testing availability and the aspirations of the Secretary of State in that regard, I start by asking the Minister about the current state of testing and tracing. From the news this morning, it would seem that coronavirus testing was being prioritised in high-risk areas, leading to shortages in others. This has led to some people with symptoms being asked to drive significant distances for a swab. The Government say that areas with fewer Covid-19 cases have had their testing capacity reduced to cope with outbreaks elsewhere. Is this within the 300,000 tests which the Secretary of State has mentioned as being his aspiration? As the Minister will be aware, public health experts warn that this could miss the start of new spikes, so I would be very grateful if he could clarify the exact position on the rollout of mass testing.

Saliva testing is being used in Hong Kong, as we know. Would the Minister be able to ensure a quick turnaround of these tests? Has he seen the study from Yale which suggests that saliva testing could be as sensitive as nose and throat swabs? What is his attitude towards pool testing, which surely could increase capacity in areas of low prevalence? Does the Minister have a plan to introduce pool testing? Will we now allow GPs to carry out testing or, at the very least, arrange tests for their patients directly? They currently have to ask patients to log on to the national system, which may be causing huge delays.

A testing problem came to my notice in an email I received from an English family on holiday in Northern Ireland. They went there to have a break and did everything they could to ensure their safe passage—they did not stop for toilet breaks, they packed lunches, they booked the shortest ferry crossing, and they were heading to a house that had not been occupied for a week. However, something went wrong, and the father became ill. He said: “Getting a test should be easy, right? Well, wrong. When we first tried to get a test, the booking system was completely down. It was not working online or by telephone. When it eventually resumed, I was offered a test appointment 460 miles, and a ferry journey, away in Scotland. I was worried about having potentially to drive 20 or 30 minutes with a raging fever, so we ordered the home tests. The kits took 48 hours to arrive. Remarkably, there seems to be no test-kit storage site in Northern Ireland itself, so they have to come from the mainland, even though one of the companies than manufactures tests—Randox—is based in Northern Ireland.”

This person had the usual problems that lots of people have when doing a self-administered test and returning the results. They were in an isolated place, so they chose to use the specially designated postal box, which meant his wife driving 25 minutes. That box was inside a building. It did not seem to cross anybody’s mind that potentially infectious people should not be entering a building full of people. When the wife talked to someone about their concerns, they said that they were not allowed to handle parcels and she should put the results in another post box. It took six days from the husband developing the fever and seeking a test to getting the result. When it came, it was not absolutely conclusive. We know that these tests can sometimes be only 70% accurate. This person is still very ill and still in Northern Ireland. He is an academic who, as it happens, is also a scientist. He is very disappointed with the 111 service, which he called to ask for another test. He was told that he could not have one, that he probably did not have Covid, and that he should go back to work. It seems to me that this system is not working terribly well. What is the Minister’s view of this sorry tale, which raises all sorts of issues about testing and tracing, at least in Northern Ireland?

I move on to the cancer plan and whether a task force will be in operation. The number of new cancer patients presenting is down by one-quarter this year, the number of appointments for specialist cancer treatment is now also falling, and the amount of money available for clinical trials has fallen through the floor. This means that people will die. What are the Government’s plans to move this forward?

We know that a vaccine is our best hope to stop this pandemic. It will save hundreds of millions of lives. We on this side of the House have offered to work with the Minister on a cross-party basis to promote uptake and challenge the poison of anti-vax myths. That offer remains in place. We would work constructively with the Government on any proposals that they bring to the House to deal with those myths.

On Public Health England, the Minister is aware that we on this side of the House think that embarking on a distracting restructuring of Public Health England in the middle of a pandemic is very risky. Conservative MPs seem to like to blame Public Health England and this will sap morale even further. The UK has suffered the highest per capita death rate of any major world economy. To get through this winter safely, our NHS and public health services need resources, staff, protective equipment, fair-pay security and the support of this Government. I hope they will be able to deliver that.

Finally, the Minister said a few minutes ago that the folic acid issue would not be dealt with until after the pandemic. He needs to write to the House about exactly what that means and what the timeline is.

[Baroness Jolly (LD)]

My Lords, yesterday it was raining when I left the house, so I decided to catch a bus. I donned my mask and got on. There were signs to say that only 30 passengers would be allowed, but I was disappointed that not only was that number exceeded, but masks were not universally worn. Some came off when the individual wanted to use their phone or talk to a friend, and there appeared to be no awareness of the reason for wearing one. I was glad to get off. It raised as many questions as it answered.

I appreciate that there is positive movement in some parts of the country. In my own part of the world, the far south-west, despite many visitors from elsewhere—the locals were anxious that they would bring the virus with them—they mainly kept to themselves and only left their footprints in the sand behind. Areas have been locked down in north-west England, Yorkshire and Greater Manchester, as there have been many cases identified. Will the Minister outline how these cases were identified?

Social distancing is difficult when you are young. We all might remember when we felt immortal; many young people catch the virus, are barely unwell but are spreaders among their generation. They then take it home and pass it on to their older family members. Mass testing would avoid this.

What is the Government’s policy on testing key workers? Do they have to book their own tests, or are some professions automatically tested or encouraged to book a test? I was contacted by text quite out of the blue by my local authority to take a test, which I dutifully did. No reason was given; perhaps it was a contact trace. I therefore looked at where the local testing stations were located and no station was nearer than 50 miles, so I ordered a postal test. Easy, excellent directions came with the test and the result came back quickly, so I had a completely different experience from that of the person who wrote to the noble Baroness, Lady Thornton. Could the Minister outline where test and trace is being used and what system is in operation? I know that it is going well in Northern Ireland. Have the Government considered using this in England?

The Government pay-to-isolate scheme also seems a good idea for those who cannot afford to miss work. Will the Minister tell the House what the take-up is and where the department might use it in future?

When do the Government expect to roll out a vaccine? I would like to know how many volunteers are taking part in the programme and how that number compares with the development of any other new vaccine that would be working to the usual timetable. I would expect Public Health England to organise vaccinations when it is ready. Now that Public Health England’s future is uncertain and it is being disbanded, how will this happen? What clinical personnel would the Government consider capable to deliver the vaccine? Presumably, as local pharmacies deliver flu vaccines, they would be capable of delivering coronavirus ones as well. Would this be something paid for by the patient, as with flu, or paid for by the Government? Has the department had conversations with the pharmacy profession about doing this work?

May I ask the Minister a question about numbers? In the Statement, it was mentioned that 84.3% of contacts were reached and asked to self-isolate. Do we have any certainty that they did so? Are local authorities or call centres checking on this?

My final point is about nurse numbers. I am delighted that they are higher, although we will still be far off full complement. Will the Minister comment on care-worker numbers? In the new year, some EU-origin workers might not be able to afford to stay under the new system. The Home Secretary suggested that we could use British care workers. Is the Minister confident that they will exist in sufficient numbers?

NHS Long-term Plan

Debate between Baroness Jolly and Baroness Thornton

Monday 1st July 2019 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for repeating the Statement and refer the House to my interests as listed in the register.

It is 71 years this week since the Labour Party created the NHS in 1948; it will also be a Labour Government who will turn around the NHS again, as we did from 1997. As the Minister will know, I welcome the things we agree on: alcohol care teams, perinatal mental health services, a greater focus on health inequalities and enabling gambling addiction services; all Labour ideas, of course. Even today the Minister—or rather, her right honourable friend—talked about bringing hospital catering in-house, which is another Labour idea.

The Minister has focused on three important matters in this Statement, but I have some questions about other matters that it contains. I want particularly to raise the question of support for local systems. Increasing the focus on population health in the long-term plan is of course very welcome. Can the Minister explain how STPs will become ICSs by April 2021, with all ICSs—I apologise to the House for using all these acronyms—reaching “mature” status, as described in the recently published ICS maturity matrix? Will the Minister also explain how the provider and commissioner landscape will develop, with a new integrated care provider contract due to be published this summer to provide guidance on how primary care can be integrated with secondary and community services?

The long-term plan rightly has prevention at its heart. Will the Minister set out how the Government will work with local authority partners to take forward prevention activities on obesity, smoking, alcohol, sexual health, antimicrobial resistance and air pollution, including how they will use the additional targeted funding being made available to support this series of activities?

At a time when life expectancy is stalling and infant mortality rates—the rate of children not making it to their first birthday—have risen three years in a row for the first time since World War II, vital public health services that tackle inequalities have been cut by £700 million. We all know that the NHS’s ability to plan for coming years is dependent upon a well-resourced adult social care system; of course, adult social care budgets have been cut by £7 billion. Also, we still await the social care Green paper. Will the arrival of a new Prime Minister hasten or further delay further its arrival? How can system-wide reform be delivered, as aspired to in the long-term plan, under these circumstances?

On staffing issues, we have 100,000 vacancies and are short of 40,000 nurses; at the same time, bursaries have been scrapped, CPD budgets cut and the no-deal Brexit we seem to be preparing for will exacerbate the staffing crisis. I noted and welcomed the interim NHS People Plan published by the noble Baroness, Lady Harding, but when will we see a workforce plan backed up by actual cash? It cannot be delivered unless this happens. The Government talk about IT systems but give no certainty on capital investment. Hospitals are facing £6 billion-worth of repairs, with walls crumbling, ceilings falling in, pipes bursting and outdated equipment stalling. Maintenance designated to address “serious risk” has doubled to £3 billion. Will this backlog also be tackled?

I turn briefly to mental health. We know that more than 100,000 children are denied mental health treatment each year because their problems are not judged “serious” enough. Over 500 children wait more than one year for specialist mental health treatment. When the Minister talks of a fundamental shift, does she mean that the Government will ring-fence funding? Given that just 1.6% of the public health budget is spent on mental health, will the Government insist that more is spent on mental health resilience and prevention?

Finally, I want to ask about next steps. It is my understanding from the Statement that a national implementation plan to be published by the end of the year will bring together the aggregated ICS/STP plans and national activities with performance trajectories and milestones to deliver the long-term plan commitments. However, it notes that the development of the national plan is contingent on the spending review, due to the need to account for decisions on workforce, social care, public health and capital budgets. Due to the uncertainty in the current political environment, will the spending review be delayed, and will that set back the development of the national plan beyond November?

The national plan states that the NHS needs to,

“remove the counterproductive effect that general competition rules and powers can have on the integration of NHS care”.

I say Amen to that. But are the Government now willing to admit that the Health and Social Care Act of the noble Lord, Lord Lansley, has had a devastating effect on the NHS? Will the Government bring forward primary legislation to achieve the objectives set out in the long-term plan?

[Baroness Jolly (LD)]

My Lords, I too thank the Minister for reading the Statement. I feel I should get out an orange flag—I am probably wearing the right colour—because, in the 1940s, Liberals were orange, not a yellowish colour. Beveridge, whose paper proposed the National Health Service, was indeed a Liberal and his proposal was for a service,

“free at the point of need”.

Anyway, I will get back to the Statement. I welcome the Secretary of State’s commitment to cancer and mental health services and workforce growth—who would not? But the Statement does not refer to the local five-year strategic plans to be completed by mid-November and rolled out thereafter. These will involve local consultation and incorporate performance trajectories and milestones across health and social care; they are truly the plans to implement the Secretary of State’s plan. The Statement mentions funding but is quiet about how much. I guess that is quite understandable given the position of the Government, who do not know who the new leader will be let alone his priorities.

The NHS is crying out for more capital: diagnostic and treatment equipment these days is big and very expensive; those of us who have been into English hospitals recently will notice that the buildings are looking sadder than they did 10, 15 or 20 years ago; and workforce shortages are mentioned. Will the Minister tell us when we can expect the NHS to be fully staffed and appropriately equipped? There is no mention of widespread regional variation in outcomes: by when will these be no more? Can the Minister explain how the areas for concentration will be managed? Will management be top-down or bottom-up, reflecting local needs?

Will the Minister also tell the House about any conversations regarding more funding for adult social care? I shall not say any more about the Green Paper. Public health services are critical to help people deal with obesity, stop smoking and become fit, so living longer, healthier lives. All these are critical matters for local authorities. The Statement barely mentions social care but, without an injection of staff and funding, it will fall, and with it the Secretary of State’s laudable visions for cancer treatment and mental health.

Tessa Jowell Brain Cancer Mission

Debate between Baroness Jolly and Baroness Thornton

Monday 13th May 2019 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for repeating the Statement. Of course, it is a matter close to the hearts of many noble Lords here, particularly those of us who took part in the debate when Tessa Jowell spoke in this House for the last time. Who could forget Tessa’s determination to fight for change, so that in the future people would not die of brain tumours but that research would lead to prevention, early detection and more effective cures, and that these would be available to everyone throughout the NHS, without being dependent on where you live? I pay tribute to Jess Mills, Tessa’s daughter, and her family for their continuing commitment to fulfilling the challenge that Tessa set all of us, as the noble Baroness quite rightly said.

We know that brain tumours are indiscriminate; they can affect anyone at any age. What is more, they kill more children and adults under the age of 40 than any other cancer, yet historically just 1% of the national spend on cancer research was allocated to this devastating disease. We all welcome the progress made so far by the Government; we congratulate them and support the fact that treatments are now available across the country that were not available when Tessa spoke to us in this House. However, we also know that the NHS faces a cancer diagnostics crisis. Cancer Research UK has pointed to chronic shortages in the diagnostic workforce, with more than one in 10 positions unfilled nationally. Hospitals are reliant on outdated equipment and some of the lowest numbers of MRI and CT scanners in the world. The UK is fourth from bottom in a league table of OECD countries with the lowest number of CT scanners per million inhabitants.

As the Minister rightly said, this is a question of both resourcing and staffing. In today’s Statement, we have been given sight of the key points that have been touched on and we are pleased that it references the upcoming workforce plan. However, it would be useful if she could expand on this point, specifically around the need for a global scientific workforce and the plans for immigration in relation to the research community. Because without the right skills and technical staff in place, a lot of the research funding and momentum achieved in the past year will not amount to very much. She will be aware that a mix of domestic and international scientific talent underpins the UK’s position as a world leader in life sciences. The 2018 immigration White Paper was not fit for purpose, in the view of those on this side of the House. The £30,000 a year salary threshold would have had a devastating impact on the recruitment of junior research capacity and the increased cost and bureaucracy requirements of the visa system. Indeed, the British public recognise the importance of an international research workforce to the UK. Ninety per cent of the public think scientists make a valuable contribution to society and 86% want to increase or maintain the level of immigration of scientists.

While I absolutely accept that progress is being made in the noble Baroness’s department, this question applies across government and I should like some reassurance that that is understood and action is being taken. Neurosurgery is no exception when it comes to the problems of cancer targets. In March 2019, the 18-week completion target for referral to treatment pathways stood at 81.3% for neurosurgery, 5% lower than the average for all specialties. This made neurosurgery the worst-performing specialty, almost certainly because of staffing shortages in these areas. Therefore, while I absolutely welcome the Statement and the progress being made, we all have to accept that we have some way still to go to fulfil the ambition and the targets that Tessa Jowell set us.

[Baroness Jolly (LD)]

My Lords, I thank the Minister for repeating the Statement. I had the honour of responding to Baroness Jowell’s maiden speech on 23 May 2016. I looked it up in Hansard this morning. She recalled Seamus Heaney’s injunction to his wife:

“‘Noli timere’—‘Do not be afraid’”.—[Official Report, 23/5/16; col. 167.]

As it turned out, we did not have long to wait for her to show how fearless she could be. I responded to her maiden speech by saying that I felt sure she would make her mark very soon. Sadly, she did not have as huge an amount of time to make her mark as I had expected—but nobody who was in the Chamber for her valedictory speech in January 2018 will ever forget her demonstration of total fearlessness.

5-ALA received FDA approval for use in the USA on 3 July 2017, just over a year after Baroness Jowell joined your Lordships’ House. Use in the UK was given NICE approval on 10 July 2018, just two months after she died. I clearly welcome today’s announcement, but I have some questions for the Minister about 5-ALA and its rollout. What weight does NICE give to treatments that have received approval by the FDA? Is it usual for a treatment that is so obviously effective to wait nearly a year before being used routinely? Will it be universally available to all those who stand to benefit from it?

Social Media and Health

Debate between Baroness Jolly and Baroness Thornton

Tuesday 30th April 2019 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for repeating this important Statement. This discussion provides a good backdrop to the debate to follow, on the online harms White Paper. There are essentially two matters of concern here: online harm and false news, which includes the health impact of anti-vax material.

After the scandal that followed the death of Molly Russell, and the bravery of her father in speaking out against the online harm perpetrated by platforms such as Instagram, we were promised decisive action, and the tragedy gave serious momentum to the content of the online harms White Paper. Mr Russell tweeted a link to a Telegraph article yesterday, saying that he had challenged Instagram and the company has said that it will now act. Coming out of yesterday’s hour-long meeting with the industry, the Secretary of State announced a few hundred thousand pounds in donations to the Samaritans for research into online harm, which is of course welcome. However, these social media platforms must be made to take responsibility for the harmful content and dangerous fake news they host.

Instagram said that it would ban all graphic and non-graphic images of self-harm in February. As far as I can see, it has not done so. Like my honourable friend Jon Ashworth MP in the Commons earlier, I did a test a couple of hours ago. To be more accurate, since I am not an Instagram subscriber, I got my researcher to demonstrate for me what happens if you type into Instagram’s search engine the term “self-harm”. You get several columns of results; the first is called “Top Results” and does not produce any links. It says that no content can be found, which is good, but I am afraid the content is still there. If you click on the next column, headed “Accounts”, there are hundreds of accounts concerning self-harm that you can access. If you click on the third column, headed “Tags”, there are 725,000 posts that mention self-harm. Some may direct you to get help but most will not, and some show graphic self-harm pictures and videos. Some of them romanticise, if you can imagine such a thing, this activity. As any health expert will tell you, for those youngsters—some are very young indeed—these are the triggers to self-harm.

The noble Baroness says that Instagram now has a policy of globally removing graphic self-harm imagery. As far as I can see, it has not done so yet. The same applies to websites concerning suicide. If you search for “#killmyself”, you will find huge numbers of results; ditto if you search for “eating disorders”. Research shows that 22 % of young adults report self-harm and suicide-related internet use. This is a crisis. There may be many reasons for this figure, and many solutions, but the internet must take responsibility for the content it contributes to this. Did the Secretary of State challenge Instagram on the assertion that it had taken down content? Has he done what my honourable friend and I did and tested it himself?

Did Instagram give a timescale, or is it waiting for the Samaritans’ research? That seems to me to be not an acceptable solution right now. I welcome the involvement of the Samaritans, but not if it means a further delay to action. It does not need research to know that the content of some of these sites is totally unacceptable and needs to be got rid of. Perhaps the noble Baroness can explain what the Samaritans’ research will be used for and its timescale? These are very, very rich organisations, and a few hundred thousand pounds to the Samaritans does not mean they can offload their responsibility to deal with this content; they have billions of pounds that can be used for this purpose.

The reason I am concerned is that these companies have form. Over many years of warm words and no change, they have consistently resisted taking responsibility for the content they carry. They have had to be pulled, kicking and screaming at every turn, into behaving with responsibility. I repeat: will the Secretary of State test this by looking at it himself?

The content of these platforms is why the White Paper is so urgently needed. I want to ask only one question about it; the debate will take place in a few moments and my noble friend will certainly pose many questions. However, if a young person even accidently accesses, for example, a self-harm image, there is a likelihood that the algorithms—which look at what every one of us is accessing online—will pick this up. While noble Lords may receive unwanted information about house extensions or the cost of flights, such a youngster may find that they are being led to more sites depicting self-harm. In other words, the algorithms can reinforce harmful content. How will the Government seek to mitigate this unintended consequence?

I turn now to the use of false information in anti-vax campaigns, which has led to a massive increase in outbreaks of measles, as the noble Baroness said in her Statement. The issue here is not just the dangerous anti-vax propaganda on platforms such as Facebook, or indeed Amazon. A story in today’s Guardian says that a young person was delivered a book, and inserted in it was an anti-vax leaflet. One has to ask how on earth it got there. The wider issue is that of public health policy and resourcing.

Are the Government considering banning unvaccinated children from schools in England, as the Secretary of State suggested on the radio last week? I hope not. Do the Government have a clear vaccination action plan? Public health services have been cut by £800 million and, in recent years, health visitors have been cut by 8% and school nurses by 24%. This will not help with the vaccination drive. Will the Government commit to reversing public health cuts and cuts to health visitors, and invest in general practice to meet the recommended 95% national vaccination coverage rate, as recommended by the World Health Organization?

[Baroness Jolly (LD)]

My Lords, I too thank the Minister for repeating the Statement. I am sure nobody in your Lordships’ House doubts the benefits, as well as the dangers, of social media. As the noble Baroness, Lady Thornton, has just stated, the tech giants really need to recognise their responsibilities by taking action now to remove material that could damage the vulnerable.

I would like to link the Statement with the NHS Long Term Plan. In it, there is a commitment to increase spending on children’s and adult mental health services. What figure will this amount to? How much of it does the department anticipate will be earmarked for technology? Where will it be directed? Who will receive the money? What does the department expect the NHS to do to support this move? What criteria will govern its use?

Vaccination uptake is clearly a current issue. How does the department anticipate that social media can help and not hinder the uptake of these life-saving shots?

European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018

Debate between Baroness Jolly and Baroness Thornton

Thursday 7th March 2019 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for introducing this instrument with such clarity. The reason I have tabled an amendment to the Motion is to draw attention to the serious concerns that were expressed by the Secondary Legislation Scrutiny Committee in its report in December last year. As the Minister has explained, these draft regulations laid by the Department of Health and Social Care set out the Government’s plans for recognition of EEA and Swiss professional healthcare qualifications in the event of no deal. Yet again we are spending valuable parliamentary time talking through quite large regulations that would not need to be here if the Government had ruled out no deal, to be frank. Here we go again. They need the scrutiny of your Lordships’ House because the Secondary Legislation Scrutiny Committee drew them to our attention, because of issues of public policy that we need to address.

The Government have said that they would not introduce new public policy issues into these orders and Brexit legislation, so we need to ask whether these regulations raise any of those issues. My questions will be focused on the issues that the Secondary Legislation Scrutiny Committee raised in its report.

The first question is about the regulators’ decision-making. The committee asked the DHSC how the UK regulators would make decisions. It was concerned about whether the regulators could set their own criteria for designation and the DHSC confirmed in its response to that question:

“Health and Care regulators are best placed to assess qualifications. Privy Council scrutiny ensures continuity for applicants in the short term whilst providing an inbuilt safety mechanism for removing qualifications that require further testing. The overarching principle behind the designation is the safety of the public—and we will work with regulators to ensure this”.


The question that the Minister needs to address is about ensuring a consistent and fair approach to the decisions by the different regulators, because each regulator will be responsible for the criteria for designation in its area.

That begs the question of how much work is involved and how much extra burden this will put on our regulators, given that the regulations give the UK regulators a discretion to designate EEA and Swiss qualifications as not acceptable in the UK after exit from the EU. The Minister needs to respond on what criteria regulators will apply in designating a qualification as not comparable to UK standards and what steps will be taken to ensure that regulators maintain a consistent and fair approach to their application. I welcome the clarification that there will be no change to the language testing arrangements, because your Lordships’ House has been concerned about that for many years.

The Minister needs to address what the administrative burden on regulators might be. No information on cost or impact is given in the Explanatory Memorandum other than to say that they will be negligible—I try to avoid that word—which seems unlikely. Given that this function requires assessment of where a qualification is not comparable and may impose an additional burden on UK regulators, we need to ask the Minister for assurances that UK regulators will have the administrative capacity and resources to deal with such decisions.

The Minister has addressed temporary and occasional qualifications, but given the number of EEA and Swiss professionals providing healthcare services in the UK on a temporary and occasional basis, she should assure us that there will be no detrimental effect on the NHS as a result of the removal of the right of EEA and Swiss professionals to work on such a basis.

I think that is enough questions for the time being. Other noble Lords will probably draw to the attention of the Minister the views that have been expressed to us by a range of organisations which have an interest in this matter, including the BMA and the royal colleges. I beg to move.

[Baroness Jolly (LD)]

My Lords, I think that there is agreement across this House that we should work to prepare this country as best we can for Brexit and the potential of a disastrous no deal. I welcome this morning’s response from the Home Office Minister in this House that she believes that no deal is unlikely.

A consequence of no deal will be that the UK is no longer part of the automatic electronic alert system between health regulators, which exchanges information on health professionals who are no longer allowed to practise in the country. The NHS is vital for our country and for the lives of our citizens. Our healthcare professionals are the backbone that holds in place the institution that we hold dear. It is imperative that the legislation is effective at retaining a frictionless flow of EEA and Swiss workforce, along with the care that they bring.

There are several areas of concern. I am concerned that impact assessments have not been done in all circumstances in relation to these SIs and that consultation has sometimes been rushed, or that little public consultation or sector consultation has been done. I intend to ask the Minister questions that are thematic. I do not mind if she does not have the time or the information to be able to respond to them today; I am quite happy for the answers to come in a letter, which I would like to be placed in the Library.

A no-deal Brexit would not allow temporary workers, and it is vague when it comes to permanent workers due to a lack of specific evidence about qualifications. I would like some light shed on this. Can the Minister confirm that, in the event of a no-deal Brexit, vital EEA medical workers will not be treated as international medical graduates—IMG—so that they can easily work for our NHS and will not have to endure long and arduous registration processes which in some cases have been known to take up to at least a year? When do the Government plan to provide guidance to healthcare professional regulators on the information required to obtain Privy Council consent to remove a qualification from automatic acceptance should they have patient safety concerns? It is important that this process can be invoked quickly should concerns arise.

How do the Government intend to approach the two-year review of the SI? Will they commit to reform of professional regulators’ legislation to allow the process for registering healthcare professionals who qualified outside the UK to be fair and consistent for all professionals, regardless of where they qualified?

I think the Minister is aware of issues around Spanish and Irish nurses. What conversations are we having with Spanish health services about the gradation of Spanish nurses to ensure that, as long as they stay here, their years working here count towards their time in the Spanish system? I had the privilege of meeting some Spanish nurses working in Taunton. They thoroughly enjoy working here but would be really anxious were this to go, because they would then feel that they would not be able to return home with any credit for the work they have done here. My noble friend Lady Thornton has already covered the issues that the scrutiny committee raised.

Moving away from the healthcare professions, why have the results of the consultation process relating to the Human Medicines (Amendment) regs and the other two SIs we are discussing not been released? Instead, the Government have provided a response that gives little transparency on any key concerns that were raised during the consultation process, or the specific organisations approached. The changes laid out in the SI are wide-ranging and many call for the establishment of new responsibilities, transference of powers or further discussions with EU counterparts. Is it realistic that the industry will be able to handle these changes in the short period remaining before 29 March and during the transition period afterwards? The MHRA does really good work and I assume that it will be taking on this work independently of the EMA, so will the MHRA receive additional funding to support this extra work?

Moving on to the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, noble Lords got very exercised about this issue in the immediate aftermath of the referendum. The impact assessment says:

“Although this contingency legislation aims to help business in their preparations for a no-deal scenario, there is a risk that due to the requirements set out, businesses will not have sufficient time to prepare. In the event of no deal being agreed with the EU before 29 March 2019, the MHRA will have regulatory processes in place so that businesses will have the relevant information to prepare for this scenario”.


Are we to take it from this that if we crash out with no deal on 29 March, not having agreed this with the EU until directly before, the regulatory process will not be in place?

I thank the Minister for listening and, as I said, I am quite happy for her to write if she is not able to respond to all these questions now.

Healthcare (International Arrangements) Bill

Debate between Baroness Jolly and Baroness Thornton

Committee: 1st sitting (Hansard - continued): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Baroness Jolly]

My Lords, the NHS in England has a long history and a good record of data governance. In 1996, Fiona Caldicott was called in and asked to look at the whole issue of NHS data. It must be said that the data was not as digital then as it is now. Her review came up with a group of principles—I think there were seven—and that was then followed by Caldicott 2. More recently, there has been another look at NHS data and we are now down to three principles. It is not just the Caldicott guardians. When he was Secretary of State at DCMS, Matt Hancock announced the data ethics framework and then we had GDPR. There is a really rich background of caring for patients’ data.

The provisions in the Bill authorising the sharing of data appear wide—that is probably the best way to put it. Clause 4(1) provides:

“An authorised person may process personal data held by the person in connection with any of the person’s functions where that person considers it necessary for the purposes of implementing”,


the Act. The words,

“that person considers it necessary”,

are a very wide formulation for the exercise of a function such as this. They seem designed to make a challenge in court almost impossible.

Among others defined as an authorised person is a “provider of healthcare”, so the authority extends beyond the NHS to all organisations that provide NHS care but might not be NHS organisations. So it would include commercial organisations as well as public authorities. Can the Minister confirm this and give an example, to better understand how wide the scope is?

Moreover, it is left to bodies such as the NHS to define for themselves the level of staff who should have this degree of authority. Will the Minister confirm how data is handled with devolved states and within the island of Ireland? How are we intending to communicate clinical data with organisations in the EU, and in the rest of the world, once the Bill has been enacted? Are there issues about shared datasets? We are fairly confident about sharing research data, but clinical data will be absolutely key here.

[Baroness Thornton]

My Lords, I have an amendment in this group. I support the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. Clause 4 of the Bill provides the legal basis for processing personal information and data about patients to facilitate patient information and payments for reciprocal healthcare after Brexit—whether as part of an agreement with the EU, an agreement with a country outside the EU or in connection with contingency plans arising from a no-deal scenario. It also seeks to ensure that the key safeguards which should always be at the heart of systems that use and exchange patients’ sensitive personal and medical data are in place. The noble Lord, Lord Patel, is right to press this issue. It was almost the first thing that he and I spoke about when we talked about the Bill, which made me look at and ask why he and other noble Lords, particularly those in the medical profession, were very concerned about this.

At Second Reading the Minister acknowledged that there were deep concerns raised by noble Lords on data processing provisions in Clause 4, and promised to address them—but unfortunately she ran out of time on that day. We look forward to her catching up with that. We know that the noble Baroness has special expertise and experience in this field, so I look forward to hearing her talk about how she envisages the necessary robust standards, security and safeguards applying in post-Brexit healthcare deals with the EU and the rest of the world, and how those will be achieved.

In the Commons, my colleagues pressed this matter with the Minister, Stephen Hammond. He gave an assurance that the powers to access personal data would be limited, and committed at the time to provide a briefing. I wanted to raise that with the Minister—my colleagues in the Commons certainly have not received that, but I thought that she might raise it with her colleague and see what the briefing might have said. I am sure that we too would be interested to receive it.

When I raised this issue at Second Reading, I mentioned that I had been in touch with the National Data Guardian for Health and Social Care, who, as we know, has a vital role in ensuring that confidential healthcare data is used and shared appropriately in protecting the high standard of confidentiality. Pursuing that question is whether the Minister has been in touch and sought her guidance on this matter.

[Lord O’Shaughnessy (Con)]

My Lords, this has been an important discussion on an area that is, of course, of growing concern not just for people in Parliament but for the general public. Noble Lords will also know about my interest in this issue; we have had many discussions over the last few years about it. It is critical that we get this right, to allay any fears—because there are fears that attend to the use and movement of data for various purposes.

The noble Baroness, Lady Jolly, makes the point in her amendment about the Caldicott principles and so on. I was pleased from the Government’s point of view to be able to bring the National Data Guardian on to a statutory footing, as well as other measures that we took to provide that level of reassurance. My understanding is that these are all part of the scaffolding around the Data Protection Act, which is the GDPR as put into our legislation. They are a way of translating the general provisions of that into healthcare purposes. I ask the Minister to confirm that, because the Bill clearly states that the Data Protection Act is the governing piece of legislation here, it therefore follows that things such as the NDG, the principles and other things apply. They, in effect, derive from that and apply to all aspects of healthcare, including reciprocal healthcare.

Long-term Plan for the NHS

Debate between Baroness Jolly and Baroness Thornton

Tuesday 19th June 2018 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for repeating this Statement. I also declare an interest as a member of a local clinical commissioning group.

It would indeed be churlish to say that an injection of funding into our NHS is not welcome right now. However, the 70th birthday present is an uplift in funding of below the 60-year average—from 1948, the birth of the NHS, to 2010, it is just on 4%. Of course, we would all, not least the patients and staff, welcome not having to face another winter crisis like the one we have just had. After what, I suspect, were some serious tussles within the Government about quantum, timing and explanation of where the funding will come from, the Minister and his colleagues must be a little disappointed in the headlines that have been generated so far. The IFS said, with respect to the Brexit dividend that,

“over the period, there is literally zero available”.

Sky News has done a data poll which suggests a majority of people do not believe there will be a Brexit dividend to help to boost NHS funding, a reaction made more unpalatable to the Government because the same polls show that a majority of people, 54% to 38%, say that they would be happy to pay more tax to fund the NHS, which we in the Labour Party have known for quite some time. In 2002, when the then Prime Minister Tony Blair made a commitment to massively increased funding to the NHS, he also announced an increase in national insurance to pay for it. He and then Chancellor Gordon Brown had spent two years preparing for that announcement and preparing the plans for the investment in the NHS that was necessary to turn it round from the previous 18 years of Conservative neglect and underfunding and to deliver the waiting list targets, cancer treatment targets and A&E targets which then followed. So when Theresa May says, as she did over the weekend, that Labour spent only half of the increased expenditure on patient care, that is completely misleading and plain wrong. If she means that replacing falling-down buildings and worn-out equipment, paying staff decent wages, and investing in massively increasing the number of doctors and nurses available is in some way not spending money on patient care, one has to question the right honourable lady’s understanding of what the NHS is and what it does.

Leaving aside the issue of how the £20 billion will be raised, we do indeed need to address how it can best be spent. We recognise that it will take time and planning to work out how to make the best use of this funding over 10 years. The challenge is huge because the prevailing state created by a combination of cuts for both health and social care, and the overcomplex bureaucracy of the NHS as a result of the Health and Social Care Act, make this a serious challenge. Waiting lists of 4 million last winter in the NHS were so severe it was branded a humanitarian crisis. Some 26,000 cancer patients are waiting more than 60 days for treatment. There have been billions in cuts to local government and social care.

My questions to the Minister start with three basic ones about the legal obligations of the NHS. These were also asked by my honourable friend Jonathan Ashworth. Will the waiting list for NHS treatment be higher or lower this time next year than the 4 million it is today? This time next year, will there be more or fewer patients waiting more than 60 days for cancer treatment? This time next year, will there be more than 2.5 million people waiting beyond four hours in accident and emergency or fewer—a target not met since 2015?

If the Secretary of State wants, as he says he does, to transform the health and social care system, how will he do this when every economic expert, from the Institute for Fiscal Studies to the Health Foundation, tells us that with a growing ageing population—which the Minister mentioned—increasingly living with long-term conditions, this announcement will do nothing more than see the NHS stand still? As my honourable friend Liz Kendall put it yesterday:

“We cannot put the NHS on a steady financial footing without a proper funding settlement for social care, yet the Secretary of State now says that that will not happen until the spending review, which in reality means no substantial extra money for social care until 2020 at the earliest. We cannot transform care for older people or reduce pressure on the NHS until we look at the two together”.—[Official Report, Commons, 18/6/18; col. 63]


Why are the Government still ducking that vital integration issue?

Why is the social care Green Paper delayed yet again, and how can this funding be used to mitigate the £7 billion in cuts and 400,000 people losing care support? How will the Government bring together health, social care, parity in mental health and the essential preventive work of public health, when they are scattered across different delivery bodies, often with differing commissioning regimes and accountable sometimes to different regulatory regimes? How will that be done under the proposals for the 10-year plan? Will this injection of funding ensure that we have a service with new models of care fit for the 21st century? Finally, we have a £5 billion repair bill facing our NHS right now, and outdated equipment. When will the Government start investing in the fabric and equipment of the NHS?

[Baroness Jolly (LD)]

My Lords, I too thank the Minister for his Statement. I welcome any increase in funding. Should the Chancellor be wondering how to pay for it, we on these Benches would be quite happy to see a 1% increase on income tax, for starters. The IFS has said that increases of close to 4% are needed for social care, as well as a funding boost for the NHS. Yet the Statement had nothing to say on this vital issue. We all know that the NHS cannot function efficiently unless social care is working well too. Many local authority leaders are indignant that the Green Paper has been moved further down the track, so when the new funding does arrive there is already a sizeable deficit to claw back. They are extremely anxious about the situation with adult social care funding being insufficient for this financial year.

What conversations have been held with the LGA, local council leaders and the Ministry of Housing, Communities and Local Government in advance of these statements? We are also dismayed about the silence on mental health, public health and community health funding. One in four of us will be affected by mental illness, there is an obesity epidemic among our children, too few health visitors, and we are critically short of psychiatric social workers. Is the Minister confident that these issues can wait until the autumn NHS plan and the Budget?

Human Fertilisation and Embryology (Amendment) Regulations 2018

Debate between Baroness Jolly and Baroness Thornton

Tuesday 27th February 2018 Grand Committee

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for explaining these regulations with clarity. I have to confess that I have form with regard to the Human Fertilisation and Embryology Authority and its regulations which goes back to when I first arrived in your Lordships’ House 20 years ago. I have been involved in the development of these regulations at each stage as a Back-Bencher or a Health Minister or in opposition. The meticulous attention that this House has given to these matters at each stage is one of the reasons why we are a world leader in the use of embryos and human tissue to advance medical and fertility science, and we should be proud of that.

Like my honourable friend Sharon Hodgson in the Commons, we on these Benches will be supporting the updating and tightening of the regulations that these statutory instruments contain. It is important that these objectives support our aim of making sure that human tissue is stored and used safely, ethically and with proper consent, and is moved properly. I am pleased that the chief executive of the Human Tissue Authority, Allan Marriott-Smith said:

“We are committed to working with our stakeholders to ensure a smooth transition and proportionate approach to implementation”.


I have two questions for the Minister. First, how will that implementation be monitored by the Government? I am not actually expecting her to answer my second question today but I would like the Government to address it. Her remarks and those of her honourable friend the Minister in the Commons show, in almost their first sentence, that these regulations are being laid as a result of a European directive, so she will not be surprised that my question relates to that. In the Commons, the Minister’ said:

“the regulations fulfil a UK obligation as a current member of the European Union. More importantly, they bring into UK law provisions to enhance our already robust controls”,—[Official Report, Commons, Third Delegated Legislation Committee, 31/1/18; col. 4.],

and so on. The Minister must therefore have anticipated that my question is: what will happen to these regulations and to this function after Brexit? Are those discussions in hand? What is their timescale? If the Minister does not have those answers to hand, I am very happy for her to write to me about them.

[Baroness Jolly (LD)]

My Lords, I thank the Minister for her introduction. I do not intend to detain the Committee long. These two regulations are, I suspect, the first of many health regulations that transpose EU law into UK law. I shall outline my understanding. As the Minister has just outlined, there are two key directives: the coding directive and the import directive, the first to ensure traceability and the second to ensure imported tissues and cells meet quality and safety standards. As I see it, the aim of these SIs is to transpose these provisions in the coding and import directives. For many patients, it is critical that this is right. What was particularly interesting in the briefings were the impact assessments that accompanied them. The transition tables enable clarity about how elements of EU legislation are put into UK law and allow us to match one for one to ensure that nothing has been altered or omitted. As far as my inexperienced eye could tell, that has been achieved. Another interesting point is the cost to the sector of the work to achieve this.

I have a few questions for the Minister, of which I have given her prior notice. Will she tell the Committee what consultations were done and with whom? What practical changes will the sector see and how long is the sector allowing for such changes to take place, if any? What cost implications are there for both organisations? Much work has been done. Was it budgeted for in their income when they were funded or has the cost had to be found from existing budgets?

As I said earlier, these are our first regulations, and I wonder whether the Minister could tell us how many more to expect and the likely total cost of this exercise to the NHS. Does she anticipate that we will be able to process these changes before leaving the EU? Does she have any indication of whether this exercise is prioritised, or do the regulations come as they are available? I spoke to both the HFEA and the HCA and they are both content with these regulations, so we are also happy to endorse them.

Maternal Safety Strategy

Debate between Baroness Jolly and Baroness Thornton

Tuesday 28th November 2017 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for repeating this important and very serious Statement today. To lose a baby is a heartbreaking matter for parents and families, and something from which sometimes they never recover. Clearly, it should not be so hard for parents to find out what may have gone wrong and why they do not have the healthy baby that they were so eagerly anticipating. So it is quite right to have a much simpler and more transparent process to find out whether anything went wrong, what it was and whether it might have been avoided, and to apologise in a timely fashion if things went wrong.

I welcome the announcement that all notifiable cases of stillbirth and neonatal death in England will now receive an independent investigation by the Healthcare Safety Investigation Branch. The HSIB is a new organisation; are we going to see primary legislation in this Session establishing it? This development is definitely an important step that could bring certainty and closure to hundreds of families every year. We on these Benches also welcome the moves by the Secretary of State to allow coroners to investigate stillbirths. There is much else to welcome in this, including the tobacco control plan, which is a passion of my own.

Our National Health Service offers some of the best neonatal care in the world, and the progress set out today is a tribute to the extraordinary work of midwives and maternity staff across the country. However, it is shocking and heartbreaking that in nearly 80% of the cases referred to by the Minister, improvements in care might have made a difference to the outcome for the baby when things have gone wrong. There is no doubt that staffing shortages mean that midwives are under enormous pressure, which can lead to situations that have a devastating impact on families. While of course we welcome the Secretary of State’s ambition to bring forward to 2025 the target date for halving the rate of stillbirths, neonatal deaths, maternal deaths and brain injuries that occur during or soon after birth, that can be delivered only if the NHS units providing those services are properly resourced and properly staffed.

I looked in vain for something in the Statement to tackle the low levels of maternity staff, an issue that is clearly linked to safety. Noble Lords will know that the heavy workload in maternity units was among the main issues identified by today’s report, with service capacity in maternity units affecting over one-fifth of the deaths reviewed. Earlier this year, research revealed that half of maternity units had closed their doors to mothers at some point in 2016, with staffing and capacity issues the most common reasons. The Royal College of Midwives tells us that we are around 3,500 midwives short of the number needed, and this summer, for the first time, there were more nurses and midwives leaving the register than joining it. This issue will be exacerbated by the fall-off of new recruits from Europe post Brexit.

A survey published by the National Childbirth Trust this year showed that 50% of women having babies experienced what NICE describes as a red-flag event. These are indicators of dangerously low staffing levels, such as a woman not receiving one-to-one care during established labour. What action will the Government take alongside some of these excellent proposals properly to address the staffing shortages as part of the strategy to improve safety? I hope that the Minister can reassure us today that the Government will provide the resources that NHS midwives and their colleagues need to deliver on these ambitions.

Finally, if and when parents resort to legal remedies, as they sometimes feel they have no choice but to do, do the Government intend to deal with the performance of the NHS Litigation Authority in terms of both timeliness—acknowledging fault in a timely manner—and learning lessons which are properly disseminated? As the Minister quite rightly said, we must have a learning culture, but one area which fails is the conduct of the NHS Litigation Authority.

I thank the Minister for the Statement, and we would be very interested in working with him to put legislation on the book that makes these proposals happen.

[Baroness Jolly (LD)]

My Lords, I pay credit to our midwives, who do a wonderful job all across the country, and to those who campaigned to get the report and have spoken about it—I woke up this morning to a very moving Radio 4 piece on the “Today” programme.

I also welcome the Statement from the Secretary of State. Bereaved parents certainly want an answer, and this is an ideal way of helping them to reach some sort of closure. One of the critical points that the Each Baby Counts report makes about maternity care is the importance of continuity of care both for the expectant mother and for the team in the delivery suite. Staffing is an issue, with the workforce being short by 3,500 and a third of our midwives approaching retirement. Some midwives are adopting different patterns of work or choosing to leave the profession, but temporary midwives, be they bank or agency, are not the solution. They undermine the continuity that is so critical. A perfect storm is approaching about recruitment and retention.

Will the Government reconsider some form of financial support for midwives in training? Are any other incentives being considered? Will they guarantee an NHS midwife who is an EU national a job should we leave the EU? What measures are being considered to bolster the morale of NHS midwives, because at the moment, it is really quite low?

Consumer Rights Bill

Debate between Baroness Jolly and Baroness Thornton

Wednesday 29th October 2014 Grand Committee

[Baroness Jolly]

The noble Lord, Lord Deben, says that this is a tricky issue and he is clearly right. One of the tricky bits of this amendment is that many aspects of internet behaviour can be fitted under these amendments. The ones in my comments relate to those of the noble Lord, Lord Best, in which people using voice over internet protocol have been wrongly charged for it. Nobody wants to see that situation but I question whether there is a need to change the law to tackle such behaviour as we have good and robust protections in place for consumers.

I also understand that companies which block services such as Skype no longer offer packages that do so, except on legacy tariffs, so these terms and conditions should not apply. I also understand that the regulator Ofcom has been in dialogue with the providers, and that there is a commitment to review the wording in their terms and conditions to ensure that these are not misinterpreted in this way.

The noble Baroness, Lady Thornton, asked about the assessment of the two-tier internet. The Government’s intention is to ensure an open, secure and safe internet. Where some services are blocked, we want to see transparency. However, our experience is that competition is working. The proposals in the US are informed by the US market. The UK’s market is very different, so we watch with interest to see what the FCC will do.

More broadly, the Government and industry through the Broadband Stakeholder Group have done a great deal of work together to ensure that there is greater transparency. For example, two industry codes of practice have now been developed. This, coupled with the UK’s highly competitive telecoms market, has been very successful in ensuring that there is no consumer detriment caused by traffic management problems.

I hope that this gives some reassurance to noble Lords proposing the amendments. However, given their wide applicability, it makes an awful lot of sense to convene a meeting on this issue with interested parties before Report. Therefore, I ask the noble Baroness to withdraw the amendment.

[Baroness Thornton]

I thank the Minister and the noble Lords, Lord Deben and Lord Best, for their remarks.

I was getting quite cross until I heard the Minister read out her last paragraph, as I thought that her remarks showed a level of complacency which I do not think is justified. As the noble Lord, Lord Deben, said, this is a complex area. I would certainly like to take the Minister up on her offer of discussions before the next stage of the Bill. I beg leave to withdraw the amendment.

Female Genital Mutilation

Debate between Baroness Jolly and Baroness Thornton

Thursday 6th March 2014 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I think we all know that what we really need is a successful prosecution for FGM. On a different point, have the Government considered conducting a national confidential inquiry into patient outcomes on female genital mutilation? They could do a survey across the NHS, which might help to give a clearer picture. Is the noble Baroness prepared to talk to her friends in the department to see whether that is a possibility?

[Baroness Jolly]

My Lords, I think that everyone agrees that a prosecution is long overdue. We are told that there are prosecutions in the pipeline. Certainly, I am more than happy to take the noble Baroness’s suggestion back to the Department of Health.

Health and Social Care Bill

Debate between Baroness Jolly and Baroness Thornton

Monday 5th December 2011 Lords Chamber

[Baroness Jolly]

My Lords, I wish to add something on Clause 51 stand part. I am sorry that it is not where we expected it, but that is absolutely fine. We are in a place of unintended consequences, because without a PCT there is no home for this particular service. Also, post-Shipman, there is a need for sharpening up clinical governance on death certificates. Therefore, there is no disagreement with any of that, but the unintended consequence is that local authorities have a serious problem in that, as I understand it, funeral directors no longer wish to be a part of the mix, so local authorities are being tasked with implementing a system in which something will have to be collected—somewhere in the order of £150 per certificate to cover the costs. The call for the system to be set up came in 2009; the previous Labour Government asked us to look at regularising the system of certification of deaths not only for cremations but for burials. It was to be revenue-neutral, which poses another problem for the local authorities.

The timing of this for somebody who is bereaved is really difficult. If you lose somebody, you can neither bury them nor have them cremated without the death certificate. Being charged something in the region of £150 could be really awkward, difficult or maybe even impossible. If they paid into an insurance plan, it will not have paid out; after a few days, probate is just not in the right place at all. I would like the Minister to consider two things. First, the cost is anticipated to be somewhere between £40 million and £60 million. I cannot think of anything else on which the taxpayer actually pays for the collection of government data. I would like the Government to consider whether it is appropriate to pass on these fees when certificates for births, marriages and deaths are currently less than £20. Secondly, failing that, would my noble friend commit to working with the Department for Communities and Local Government and the Ministry of Justice to devise a sensitive system that does not call for a sizable payment up front on collection of the death certificate? They should pay attention to the pilot data alluded to by the noble Baroness, Lady Finlay; the pilots are not running absolutely smoothly.

[Baroness Thornton]

My Lords, what links the two parts of this debate are the unintended consequences and the need for second and third thoughts about things. My noble friend Lord Patel, the noble Lord, Lord Adebowale, and the noble Baroness, Lady Hollins, expressed concern about this clause. That is frankly good enough for me. It has been suggested elsewhere in the way of things that some enthusiastic civil servants, in the process of tidying up this Bill, have actually brought about what could be serious unintended consequences. The noble Baronesses, Lady Murphy and Lady Barker, also have some important points to make about the amendment in the name of the noble Baroness, Lady Barker. This House spent many hours constructing the architecture through the Mental Capacity Act and the Mental Health Acts, not all of it right. I do, however, remember the duty of co-operation being an important part of those Acts; those rights, protections and duties are very important and we need to check that we have not damaged them through the construct of this Bill.

On Clause 51 stand part, we on these Benches are pleased to support the important amendment put down by the noble Baroness, Lady Finlay, about the problems that might occur when the responsibilities of primary care trusts for the certification of deaths are transferred to local authorities. I do not intend to read out the whole of this note because the noble Baroness, Lady Jolly, has referred to most of it, but we are very concerned that these proposals will mean delay and an increase in cost when people are at their most vulnerable and least able to withstand that. I do not think that anybody in this House would want that to happen. I suspect that the Government would not want to place in jeopardy the trust and confidence in the system as it is, and I think there is a danger that Clause 51 does that. We on these Benches support the amendments in this group.

Health and Social Care Bill

Debate between Baroness Jolly and Baroness Thornton

Monday 7th November 2011 Lords Chamber

[Baroness Jolly]

My Lords, given the hour, I shall be brief. I understand exactly why the noble Baroness, Lady Gibson, has tabled the amendment. I come from the south-west and my GP practice is 25 miles from where I live. The hospitals are 25 or 50 miles away. The noble Baroness and I share that sort of background. The amendment would work in the south-west, the north-west, the north-east, or even north-east Lincolnshire. We have factors of distance, sparsity and rural poverty which are often hidden in poorly measurable clusters.

Before I came here I had a view about policy and legislation being made in a bubble in the south-east and being very metropolitan-based. I had hoped that when I arrived here I would find to the contrary, but I confess that I have not. For a while I was linked with a Defra team and corresponded with a Defra Minister about rural-proofing legislation. It is fair to say that he was not hugely optimistic, but someone really needs to say, “Would it work in a rural area?”. My noble friend Lord Greaves has already started this job on the Bill and has tabled an amendment—and I fear there may be more—about district councils. They play a hugely vital part in areas of rural England that have not become unitary authorities. In one or two areas of the Bill—perhaps in a few more—there are instances where district councils need to be factored in.

Perhaps the Government should have some sort of rural policy champion—I hesitate to use the word tsar. I should be grateful if the noble Earl would give us his assurance that that will happen for this Bill.

[Baroness Thornton]

My Lords, my noble friend Lady Gibson is to be congratulated. I particularly indentify with her remarks about dispensing chemists. As she knows, I supported her on this when I was on the other side of the House, and the issue is close to my heart. She and the noble Baroness, Lady Jolly, have raised a very valid issue and I look forward to hearing the Minister’s remarks.